PureSet™ PUR1001

GUDID 07332747198195

NobelZygoma™ PureSet Plate

Nobel Biocare AB

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 07332747198195
• NIH Device Record Key: d95eb5ad-0f3e-4da9-927b-f6b463465c8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureSet™
• Version Model Number: PUR1001
• Catalog Number: PUR1001
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747198195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231219

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

[07332747198195]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-10
• Device Publish Date: 2023-08-02

On-Brand Devices [PureSet™]

• 07332747198195: NobelZygoma™ PureSet Plate
• 07332747198188: NobelZygoma™ PureSet Tray